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Found 9213 cases where Vaccine is PNC13

Case Details (Reverse Sorted by Appearance Date)

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VAERS ID:511877 (history)  Vaccinated:2013-11-05
Age:0.4  Onset:0000-00-00
Gender:Female  Submitted:2013-11-05
Location:Virginia  Entered:2013-11-07, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS4HP391IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH8800AA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG420281IMLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB354A1IMLL
Administered by: Private     Purchased by: Private
Symptoms: Incorrect route of drug administration
SMQs:
Write-up: Medical assistant drew oral dose Rotarix up in a syringe. Administered vaccine IM injection Right thigh. When she started documenting vaccines, realized error and brought to attention of RN and MD. See #13, letter D.

VAERS ID:511890 (history)  Vaccinated:2013-05-17
Age:0.3  Onset:2013-06-01, Days after vaccination: 15
Gender:Female  Submitted:2013-11-07, Days after onset: 159
Location:Kentucky  Entered:2013-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: X-Ray; Ultrasound; Barium enema; Surgery
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4310BA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH788AA1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13401IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451331IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.H0165311PO 
Administered by: Other     Purchased by: Public
Symptoms: Barium enema, Intussusception, Surgery, Ultrasound scan, X-ray
SMQs:, Gastrointestinal obstruction (narrow)
Write-up: Patient with intussusception x 3. Barium enema then recurrent then surgery.

VAERS ID:511929 (history)  Vaccinated:2013-11-05
Age:0.4  Onset:2013-11-07, Days after vaccination: 2
Gender:Male  Submitted:2013-11-07, Days after onset: 0
Location:Michigan  Entered:2013-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute Upper Respiratory Infection
Preexisting Conditions: GERD, Milk Protein Allergy
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSF24BP1IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.J0064181IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG173401IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0038191PO 
Administered by: Private     Purchased by: Private
Symptoms: Rash macular, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Blotchy Hives on Face Only. Chin, cheeks, and forehead, no treatment at this time.

VAERS ID:511940 (history)  Vaccinated:2013-10-14
Age:1.0  Onset:2013-11-03, Days after vaccination: 20
Gender:Female  Submitted:2013-11-07, Days after onset: 4
Location:Arizona  Entered:2013-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Urgent Care Note from November 3rd, 2013
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.J0065210IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H0202570SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG624343IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0035410SCLL
Administered by: Unknown     Purchased by: Public
Symptoms: Varicella post vaccine
SMQs:
Write-up: Physician Diagnosed Chicken Pox Infection.

VAERS ID:511949 (history)  Vaccinated:2013-10-14
Age:1.0  Onset:2013-11-04, Days after vaccination: 21
Gender:Male  Submitted:2013-11-07, Days after onset: 3
Location:Arizona  Entered:2013-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Contact Dermatitis
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.J0065210IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H0202570SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG624343IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0035410SCLL
Administered by: Private     Purchased by: Public
Symptoms: Blister, Rash erythematous, Rash maculo-papular, Varicella post vaccine
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Skin: maculopapular eryth lesions back, and vesicles in all stages compatible with varicella; few on abdomen, Cluster on right testis, which it scratches often. No lesions mucosa. Neuro: Normal strength and tone. No meningeal signs. ALLERGIC REACTION TO VARIVAX Suspected 2ry to Varivax, as there''s no cluster of varicella going on anecdotally. Due to timing , more likely than not it was caused by vaccine. Advice parents course is usually mildly and less or not contagious.

VAERS ID:511974 (history)  Vaccinated:2012-10-04
Age:0.5  Onset:2012-10-04, Days after vaccination: 0
Gender:Male  Submitted:2013-11-07, Days after onset: 399
Location:Kansas  Entered:2013-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4274AA2UNLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4527AA0IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0021AE2UNRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHU4527AA0IMLL
Administered by: Public     Purchased by: Private
Symptoms: Ephelides, Erythema, Lethargy, Pyrexia, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (broad)
Write-up: The evening of 10/04/2012, the parents noticed that patient was lethargic, hot to the touch (103 Fahrenheit temp). Parents called the doctor, and the parents alternated giving TYLENOL and ibuprofen and the fever was reduced to 102 fahrenheit. They gave patient an ice bath and noticed what they describe as "red freckles" on his entire body except on his face. They applied cold towels to his body and an hour later his temp was back to normal, he was acting normal, and the red freckles were gone in the morning.

VAERS ID:511856 (history)  Vaccinated:2013-08-23
Age:0.3  Onset:2013-10-31, Days after vaccination: 69
Gender:Female  Submitted:2013-11-06, Days after onset: 6
Location:Foreign  Entered:2013-11-07, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2013313973
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 2IMUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 2IMUN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER 2PO 
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Condition aggravated, Death, Respiratory distress, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: This is a report from a non-Pfizer sponsored interventional study. This is a report from an investigator initiated clinical research (IIR) study. A 5 month-old female subject received, at the age of 3 months, the third dose of PREVENAR 13 at 0.5 ml single dose intramuscularly on 23Aug2013. On 23Aug2013, the subject concomitantly received the third dose of DPT-Hib-HepB intramuscularly, and the third dose of polio vaccine orally. The subject had previously received two doses of PREVENAR 13, DPT-Hib-HepB and polio vaccine on 28Jun2013 and 26Jul2013. The subject had a relevant history of respiratory distress. On 31Oct2013, the subject developed respiratory distress and was hospitalized at the emergency unit of the pediatric service in the night of 31Oct2013. The event was described as follows: respiratory distress with intercostals retractions, "wing of nose beat" and vomiting; no fever nor diarrhea. The subject was treated with oxygen and unspecified antibiotics. It was reported that on an unknown date the subject died due to respiratory distress. The investigator assessment of the causal relationship of the respiratory distress with the PREVNAR 13 was provided as "unclear" at the time of this report. The case is managed as if the investigator''s assessment was that a reasonable possibility exists that the event was related to the study product, as a cautionary measure and for reporting purposes. This is a preliminary report for notification of a fatal/life threatening event.

VAERS ID:511859 (history)  Vaccinated:2013-01-01
Age:68.0  Onset:2013-01-23, Days after vaccination: 22
Gender:Female  Submitted:2013-11-05, Days after onset: 286
Location:Foreign  Entered:2013-11-07, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension; Asthmatic; Elastoplast allergy, Allergic to all sticking plasters except micropore
Diagnostic Lab Data:
CDC 'Split Type': 2013311296
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Fatigue
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: This is a spontaneous report from a consumer via the contactable Medicines and Healthcare Products Regulatory Agency (MHRA), received under reference number GB-MHRA-ADR 22290757. A 68 year old female of unknown ethnicity received pneumococcal conj vac, 13-val parenteral, in Jan2013. Medical history included hypertension, ongoing asthma, ongoing elastoplasts allergy (allergic to all sticking plasters except micropore). Concomitant medication included VENTOLIN, SERETIDE, ramipril, bendroflumethiazide, doxazosin, amlodipin, glucosamine sulphate and omega-3 fish oil. On 23Jan2013, the patient experienced dizziness. Dizzy spells not experienced previously. In Feb2013, the patient experienced shortness of breath that was not improved by taking VENTOLIN and she also tired all the time. Mentioned to General Practitioner after this had continued for a few months, and the doctor took no action. At the date of report, the patient had not recovered from the events. The reporter considered the events to be serious due to being medically significant. The MHRA considered the event to be serious for an unspecified reason. No follow-up attempts are possible. No further information is expected. Pfizer is the Marketing Authorization Holder of pneumococcal 13-cal conj vac in the reporter''s country. This may be a duplicate in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac has submitted the same report to the regulatory authorities.

VAERS ID:511865 (history)  Vaccinated:2013-09-03
Age:0.3  Onset:2013-09-07, Days after vaccination: 4
Gender:Male  Submitted:2013-11-05, Days after onset: 59
Location:Foreign  Entered:2013-11-07, Days after submission: 2
Life Threatening? No
Died? Yes
   Date died: 2013-09-12
   Days after onset: 5
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Milk allergy
Diagnostic Lab Data: 08-SEP-2013, Body temperature, 38 Centigrade
CDC 'Split Type': 2013312399
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Cough, Crying, Death, Diarrhoea, Faeces discoloured, Fluid intake reduced, Nasopharyngitis, Restlessness, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: This is a spontaneous report received from the foreign Health Authority (Regulatory Authority reference number: GREOF-20130360). A nurse (mother) reported that her 3 months and 26 days old, non-breastfeeding (due to milk allergy) male infant, born at 38 weeks via caesarean section (weight at birth 3850 kg), was vaccinated with MENJUGATE and PREVENAR-13, both on 03Sep2013 at 0.5 ml single dose. No concomitant medications were administered to the infant. Between 07Sep2013 and 08Sep2013 the infant presented catarrh and mild cough. As of 08Sep2013 he presented severe restlessness, sleep disorder (limited sleep), severe intermittent crying lasting 1 to 1.5 minutes each time, reduced milk intake to half, rectal temperature at 38 degrees Centigrade, stools watery and green-coloured. The infant was examined by a pediatrician on 11Sep2013 who could not diagnose something significant. On 12Sep2013 the infant went to sleep and never woke up.

VAERS ID:511868 (history)  Vaccinated:0000-00-00
Age:0.9  Onset:0000-00-00
Gender:Female  Submitted:2013-11-06
Location:Foreign  Entered:2013-11-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2013312426
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site cyst, Injection site reaction, Muscle necrosis
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad)
Write-up: This is a spontaneous report from a contactable physician via a sales representative who reported for 4 children. This is 2 of 4 children. A 10-month-old female patient of an unspecified ethnicity received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history was not reported. Concomitant medication included HepB vaccine. On an unspecified date, the patient developed large cysts on right thigh and muscle necrosis, that required hospitalization. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. The physician has also reported that 4 children were recently seen by various paediatricians and presented with large cysts on their right thighs after the 9 month vaccines, one being PREVENAR. The reaction was not immediate but a few days later. Another paediatric surgeon reported that it looked like a muscle necrosis. He operated on all 4 of these children and there have been no come backs since. The physician''s concern is that he has not seen this reaction from vaccines, and that they were all in the right thigh, in a space of a month and at the same time of the vaccine schedule. Another physician also reported this as being unusual.

VAERS ID:511870 (history)  Vaccinated:0000-00-00
Age:0.8  Onset:0000-00-00
Gender:Female  Submitted:2013-11-06
Location:Foreign  Entered:2013-11-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2013312431
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cyst, Muscle disorder
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: This is a spontaneous report from a contactable physician via a sales representative who reported for 4 children. This is 4 of 4 children. A 10-month-old female patient of an unspecified ethnicity received PREVENAR, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported. Concomitant medication included HEPA-B VAC. On an unspecified date, the patient developed large cysts on right thighs and muscle narcosis, that required hospitalization. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. The physician has also reported that 4 children were recently seen by various Paediatricians and presented with large cysts on their right thighs after the 9 month vaccines, one being PREVENAR. This reaction was not immediate but a few days later. Another Paediatric Surgeon reported that it looked like a muscle narcosis. He operated on all 4 of these children and there have been no come backs since. The physician''s concern is that he has not seen this reaction from vaccines, and that they were all in the right thigh, in a space of a month and at the same time of the vaccine schedule. Another physician also reported this as being unusual.

VAERS ID:511881 (history)  Vaccinated:0000-00-00
Age:0.9  Onset:0000-00-00
Gender:Female  Submitted:2013-11-06
Location:Foreign  Entered:2013-11-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2013312341
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site cyst, Injection site reaction, Muscle necrosis
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad)
Write-up: This is a spontaneous report from a contactable physician via a sales representative who reported for 4 children. This is 1 of 4 children. A 10-month-old female patient of an unspecified ethnicity received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history was not reported. Concomitant medication included HepB vaccine. On an unspecified date, the patient developed large cysts on right thigh and muscle necrosis, that required hospitalization. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. The physician has also reported that 4 children were recently seen by various paediatricians and presented with large cysts on their right thighs after the 9 month vaccines, one being PREVENAR. The reaction was not immediate but a few days later. Another paediatric surgeon reported that it looked like a muscle necrosis. He operated on all 4 of these children and there have been no come backs since. The physician''s concern is that he has not seen this reaction from vaccines, and that they were all in the right thigh, in a space of a month and at the same time of the vaccine schedule. Another physician also reported this as being unusual.

VAERS ID:511882 (history)  Vaccinated:0000-00-00
Age:0.8  Onset:0000-00-00
Gender:Unknown  Submitted:2013-11-05
Location:Foreign  Entered:2013-11-07, Days after submission: 2
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood culture confirmed that baby died of strep pneumo meningitis (Unknown date)
CDC 'Split Type': 2013312160
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture positive, Death, Meningitis pneumococcal
SMQs:
Write-up: This is a spontaneous report from a contactable physician via a sales representative. A 9-month-old patient of an unspecified gender received PREVENAR 13, via an unspecified route of administration on unknown date. The patient medical history and concomitant medications were not reported. The patient developed streptococcus pneumoniae meningitis on an unspecified date that required hospitalization. The patient died on an unspecified date. Blood culture confirmed that baby died of streptococcus pneumoniae meningitis. It was not reported if an autopsy was performed. Follow-up attempts completed. No further information expected.

VAERS ID:511891 (history)  Vaccinated:0000-00-00
Age:0.9  Onset:0000-00-00
Gender:Female  Submitted:2013-11-06
Location:Foreign  Entered:2013-11-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2013312430
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site cyst, Injection site reaction, Muscle necrosis, Surgery
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad)
Write-up: This is a spontaneous report from a contactable physician via a sales representative who reported for 4 children. This is 3 of 4 children. A 10-month-old female patient of an unspecified ethnicity received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history was not reported. Concomitant medication included HepB vaccine. On an unspecified date, the patient developed large cysts on right thigh and muscle necrosis, that required hospitalization. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. The physician has also reported that 4 children were recently seen by various paediatricians and presented with large cysts on their right thighs after the 9 month vaccines, one being PREVENAR. The reaction was not immediate but a few days later. Another paediatric surgeon reported that it looked like a muscle necrosis. He operated on all 4 of these children and there have been no come backs since. The physician''s concern is that he has not seen this reaction from vaccines, and that they were all in the right thigh, in a space of a month and at the same time of the vaccine schedule. Another physician also reported this as being unusual.

VAERS ID:511906 (history)  Vaccinated:2013-09-25
Age:0.2  Onset:2013-09-26, Days after vaccination: 1
Gender:Unknown  Submitted:2013-11-07, Days after onset: 42
Location:Foreign  Entered:2013-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis; Eczema asteatotic; Trichiasis
Preexisting Conditions:
Diagnostic Lab Data: Blood tests (26-SEP-2013): Showed nothing abnormal; Abdominal X-ray (26-SEP-2013): Showed nothing abnormal; Ultrasonic test (26-SEP-2013): Showed nothing abnormal; Rectal test (02-OCT-2013) showed no blood attached; Body examination (02-OCT-2013) showed the baby''s condition was quite good
CDC 'Split Type': WAES1310JPN004795
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR 0SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 0SYRUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.H0187770PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Blood test normal, Feeding disorder, Haematochezia, Rectal examination normal, Ultrasound scan normal, X-ray normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: This spontaneous report was received from a physician concerning a 2 month old patient with trichiasis and xerotic eczema who on 25-SEP-2013 was vaccinated with the 1st dose of ROTATEQ (lot # H018777; expiration date 20-JUL-2014) 2 ml, orally. Suspect therapy included the 1st dose of HEPTAVAXII (lot # not reported) 0.25 ml, subcutaneously vaccinated on 25-SEP-2013, ACTHIB injection drug, vaccinated on 25-SEP-2013 (dose and indication not reported) and PREVENAR injection drug, vaccinated on 25-SEP-2013 (dose and indication not reported). There was no concomitant medication. The patient was fed by milk instead of breast feeding. On 25-SEP-2013, the patient received the first vaccinations of ROTATEQ, HEPTAVAXII, ACTHIB and PREVENAR at the same time. On 26-SEP-2013, the patient visited the clinic of the reporting hospital in the morning for trichiasis and infantile xerotic eczema. At that time, there was no adverse reaction and the patient seemed to be in good condition. After reaching home, the baby''s mother called that bloody stool was found out and it was like the form of custard cream with little streamlined blood mixed in. The baby was referred to the pediatric of Hospital A. Abdominal X-ray, ultrasonic test and blood tests were performed, but they all showed nothing abnormal. The patient was admitted to Hospital A for follow-up treatment. What his stool looked like when he was admitted into the hospital was unknown, so was the detail what treatment he had received in the hospital. There was no information on whether there were symptoms like fever or vomiting. On 27-SEP-2013, the patient was discharged from Hospital A. On 02-OCT-2013, as the bloody stool persisted, the baby was taken to the reporting hospital for treatment again. He was under artificial feeding due to some feeding problem, but he was still very active. There was something linty and red in his stool. Rectal test showed no blood attached and whole body examination also showed the baby''s condition was quite good. It was considered that the baby recovered from the bloody stool. On 11-OCT-2013, when explaining the situation to the baby''s mother through a phone call, she said that there was no blood stool anymore. On 28-OCT-2013, while the baby was taken to the reporting hospital, it was confirmed that there was no bloody stool. The patient received the second mixed vaccination of HEPTAVAXII, ACTHIB and PREVENAR. The second vaccination of ROTATEQ was postponed. Comment from the reporter: ROTATEQ was considered to be irrelevant to the onset, and the relationship between bloody stool and ROTATEQ was unknown. The reporting physician considered that the bloody stool was serious due to hospitalization. The reporting physician considered that HEPTAVAXII was considered to be irrelevant to the onset, while the relationship between bloody stool and ROTATEQ was unknown. The reporting physician also considered that ACTHIB and PREVENAR were other causing factors. Upon internal review, the relationship between blood stool and HEPTAVAXII could not be denied. Additional information has been requested.

VAERS ID:511643 (history)  Vaccinated:2013-10-16
Age:0.2  Onset:2013-10-17, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:South Carolina  Entered:2013-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Milk protein allergy
Diagnostic Lab Data: Stool cx - 10-18-2013 --$g negative; C diff - 10-18-2013 --$g negative
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS55CY50UNLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.J0064170UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG548980UNRL
Administered by: Private     Purchased by: Unknown
Symptoms: Clostridium test negative, Culture stool negative, Haematochezia, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)
Write-up: Child has a history of milk protein intolerance/bloody stools - had improved on neutramigen but stools still guaiac (+) - 1 day after 2 month vaccines (rotavirus not given) child developed grossly blood stools which have not resolved - stool cx and c diff sent at that time were negative.

VAERS ID:511648 (history)  Vaccinated:2013-11-04
Age:0.5  Onset:0000-00-00
Gender:Male  Submitted:2013-11-05
Location:Texas  Entered:2013-11-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSF24BP1UNRL
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0084230UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG173402UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0052392PO 
Administered by: Other     Purchased by: Unknown
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: Pt is doing well, acting normal, smiling playing and responsive. Parent has not reported any abnormality.

VAERS ID:511659 (history)  Vaccinated:2013-10-17
Age:0.4  Onset:2013-11-02, Days after vaccination: 16
Gender:Male  Submitted:2013-11-06, Days after onset: 4
Location:Massachusetts  Entered:2013-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Ultrasound; air contrast ememas preformed, brought to OR x 2
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4454AA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH854AB1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURJ12811IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG750641IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0038131PO 
Administered by: Unknown     Purchased by: Public
Symptoms: Barium double contrast, Diarrhoea, Irritability, Ultrasound scan, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow)
Write-up: Began with fussiness, inconsolable, vomiting at 7pm q 20 mins; called our night answering service at 2:28am; bright red watery stools as well; seen at ER ~ 3am.

VAERS ID:511673 (history)  Vaccinated:2013-10-28
Age:0.3  Onset:0000-00-00
Gender:Female  Submitted:2013-10-30
Location:Texas  Entered:2013-11-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B254AA UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH8488AA1UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG750731UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0048751PO 
Administered by: Private     Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: 4 month immunization prepared and given, 2nd week in physician''s office and administered combo DTaP/IPV (KINRIX) with medications.

VAERS ID:511773 (history)  Vaccinated:2013-10-28
Age:61.0  Onset:2013-10-29, Days after vaccination: 1
Gender:Female  Submitted:2013-10-31, Days after onset: 2
Location:New Jersey  Entered:2013-11-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic conditions (Chronic pain, Diabetes, HTN)
Preexisting Conditions: Chronic pain; Diabetes; HTN; Hyperlipidemia; GERD; Dysthymic disorder
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG52009 IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initially, bruise at right arm vaccine site, then enlarging red, swollen, painful area. Associated fever 99.4, chills. Currently under treatment.

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